WHO临床试验用药GMP指南草案解读！

WHO临床试验用药GMP指南草案解读！ 2020-11-15 23:27

WHO Draft Document on GMP for IMPs

WHO临床试验用药GMP指南草案解读

In view of recentexperiences from inspecti** carried out for COVID-19 therapeutics, the WorldHealth Organization (WHO) published a new working document entitled "GOODMANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS". The deadlinefor comments is 6 January 2021. According to the WHO the current update ofthe WHO Good manufacturing practices for investigational pharmaceuticalproducts for clinical trials in humans (WHO Technical Report Series, No. 863) document is tobring the guideline in line with current expectati** and trends in goodmanufacturing practices (GMP).

世界卫生组织(WHO)近日发布了一份新的工作文件，题为“临床试验产品的良好生产规范”。征求意见截止日期是2021年1月6日。WHO修订该指南以符合当前的期望和GMP趋势。

Scope

范围

Therecommendati** in this guideline apply to investigational medicinal products(IMPs) for human and veterinary use. The quality system shouldincorporate GxP (e.g. GLP, GMP, GCP,GSDP) including quality risk management (QRM).

本指南中的建议适用于人用和兽用临床试验药品(IMP)。质量体系应结合GxP(如GLP、GMP、GCP、GSDP)，包括质量风险管理(QRM)。

Specific aspects of the WHO draft document

该指南的具体要求

Specificati**(for starting materials, primary packaging materials, intermediate, bulk and finished products) should be available. They should include the estimated stability, if necessary, under accelerated conditi**; and the preliminary storage conditi** and the shelf life of the product.

应有标准(起始原料、内包装材料、中间体、待包装产品和成品)。必要时，应包括在加速条件下估计的稳定性；以及产品的初步贮存条件和有效期。

Change Control

变更控制

As a result of new experience in the development of an IMP, specificati** maybe changed by following a documented procedure. Changes should be authorized bya resp**ible person.

根据来自临床试验用药开发的新经验，标准可能会根据书面的程序进行变更。变更应由负责人批准。

Qualification and Validation

确认与验证

The extent of qualification and validation (analytical &production procedures) may be different to that necessary for routineproduction and should be determined based on risk assessment.

确认和验证的范围(分析和生产程序)可能不同于常规生产所需的范围，应基于风险评估进行确定。

QC & Batch Release

QC和批放行

Each batch of product should be tested in accordance with a ProductSpecification File (PSF) and should meet its specification. Productrelease can be carried out in two stages: Before final packaging(bulk product testing) and after final packaging (finished product testing).The IMP batch release should only occur after the designatedresp**ible person has certified that the product meets the relevantrequirements.

每批产品应根据产品标准文件(PSF)进行测试，并应符合其标准。产品放行可分两个阶段进行：最终包装前(待包装产品测试)和最终包装后(成品测试)。IMP批放行应在指定负责人确认产品符合相关要求后进行。

Reference & Retention Samples

标准品和留样

Reference and retention samples of each batch of product should beretained. Retention samples should be kept until the clinical report has beenprepared. The storage location of reference & retention samples shouldbe defined in a technical agreement between the sp**or and manufacturer andshould allow for timely access by the competent authorities.

应保留每批产品的参比样品和留样。留样应保存至临床报告完成。参比样品和留样的存放地点应在申办者和制造商之间的技术协议中规定，并应允许主管当局及时查阅。

Electronic Records

电子记录

It is acceptable to store information related to the final packaging as written or electronic records. Electronic systems should comply with the requirements of the WHO guideline for computerized systems.

可以接受以书面或电子记录的形式存储与最终包装相关的信息。电子系统应符合WHO计算机化系统指南的要求。

Complaints & Recalls

投诉和召回

Written procedures should be in place describing the handling ofcomplaints & recalls. Recall procedures should be understood by the sp**or,investigator and monitor, in addition to the pers** resp**ible forrecalls.

应有描述投诉和召回处理的书面程序。除负责召回的人员外，申办方、试验人员和监督人员也应理解召回程序。

Shipping & Transfer

运输

Shipping of IMPs should be carried out in accordance with written procedures laid down in the protocol or shipping order given by the sp**or. A shipment is sent to an investigator after following the defined release procedures, for example, QC and authorization by the sp**or. Both releases should be recorded. The sp**or should ensure that the shipment will be received and acknowledged by the correct addressee as stated in the protocol. Transfer of IMPs from one site to another should be done in exceptional cases only. Such transfers should be justifiable, documented and carried out in accordance with a written procedure.

IMPs的发运应按照协议中规定的书面程序或申办方提供的发货指令进行。货物在遵循规定的放行程序(例如，QC和申办方的批准)后被发送给试验人员。这两种放行均应记录。申办方应确保货物将由协议中规定的正确收件人接收和确认。只有在特殊情况下，才应将IMP从一个地点转移到另一个地点。此转移活动应予以论证，书面记录并按照书面的程序执行。

Repackaging / Relabelling

重新包装/重贴标签

Repackaging or relabelling should normally be done by the manufacturer. Records should be maintained and provide full traceability of the product and activities.

重新包装或重新贴标签通常应由制造商完成。应保存记录，并确保产品和活动的全面可追溯性。

Destruction

销毁

The sp**or is resp**ible for the destruction of unused IMPs. Unused products should not be destroyed by the manufacturer without prior authorization by the sp**or.

申办方负责销毁未使用的IMP。未经申办方批准，制造商不得销毁未使用的产品。

The Product Specification File (PSF) contains all the information necessary on the detailed written instructi** on processing, packaging, labelling, quality control testing, batch release, storage conditi** and shipping.

产品标准文件(PSF)包含所有必要的详细书面说明信息，包括加工、包装、标签、质量控制测试、批放行、储存条件和运输。